Prescribing Information

Versacloz (clozapine) Oral Suspension is an antipsychotic medication used to treat severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Common side effects include sedation, rapid heartbeat, constipation, dizziness, low or high blood pressure, fever, excessive salivation, headache, nausea or vomiting, or dry mouth.

The starting dose of Versacloz is 12.5 mg once daily or twice daily. The total daily dose can be increased in increments of 25 mg to 50 mg per day, if well-tolerated, to achieve a target dose of 300 mg to 450 mg per day (administered in divided doses) by the end of 2 weeks. Versacloz may interact with fluvoxamine, ciprofloxacin, enoxacin, oral contraceptives, caffeine, cimetidine, escitalopram, erythromycin, paroxetine, bupropion, fluoxetine, quinidine, duloxetine, terbinafine, sertraline, tobacco smoke, carbamazepine, phenytoin, St. John's wort, rifampin, other antipsychotics, antibiotics, antiarrhythmics, pentamidine, levomethadyl acetate, methadone, halofantrine, mefloquine, dolasetron mesylate, probucol, tacrolimus, antidepressants, and phenothiazines. Tell your doctor all medications and supplements you use. During pregnancy, Versacloz should be used only if prescribed. This drug passes into breast milk. Consult your doctor before breastfeeding.

Our Versacloz (clozapine) Oral Suspension Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Recurrence of Psychosis and Cholinergic Rebound after Abrupt
Discontinuation [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a
drug cannot be directly compared to rates in the clinical trials of another
drug and may not reflect the rates observed in clinical practice.

Table 9 summarizes the adverse reactions reported in
clozapine-treated patients at a frequency of 2% or greater across all clozapine
studies (excluding the 2-year InterSePT™ Study). These rates are not adjusted
for duration of exposure.

† Rate based on population of approximately 1700 exposed
during premarket clinical evaluation of clozapine.

Table 10 summarizes the most commonly reported adverse
reactions ( > 10% of the clozapine or olanzapine group) in the InterSePT™
Study. This was an adequate and well-controlled, two-year study evaluating the
efficacy of clozapine relative to olanzapine in reducing the risk of suicidal behavior
in patients with schizophrenia or schizoaffective disorder. The rates are not
adjusted for duration of exposure.

Table 10: Incidence of Adverse Reactions in Patients
Treated with Clozapine or Olanzapine in the InterSePT™ Study ( ≥ 10%
in the clozapine or olanzapine group)

Adverse Reactions

Clozapine
N = 479
% Reporting

Olanzapine
N = 477
% Reporting

Salivary hypersecretion

48%

6%

Somnolence

46%

25%

Weight increased

31%

56%

Dizziness (excluding vertigo)

27%

12%

Constipation

25%

10%

Insomnia

20%

33%

Nausea

17%

10%

Vomiting

17%

9%

Dyspepsia

14%

8%

Dystonia

Class effect: Symptoms of dystonia, prolonged
abnormal contractions of muscle groups, may occur in susceptible individuals
during the first few days of treatment. Dystonic symptoms include: spasm of the
neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty,
difficulty breathing, and/or protrusion of the tongue. While these symptoms can
occur at low doses, they occur more frequently and with greater severity with
high potency and at higher doses of first generation antipsychotic drugs. An
elevated risk of acute dystonia is observed in males and younger age groups.

Postmarketing Experience

The following adverse reactions have been identified
during post-approval use of clozapine. Because these reactions are reported
voluntarily from a population of uncertain size, it is not always possible to
reliably estimate their frequency or establish a causal relationship to drug exposure.